July 17, 2009Recalls and Safety Alerts: Update on Precipitate Formation with Ceftriaxone and Calcium-containing Products Recalls and Safety Alerts: Update on Precipitate Formation with Ceftriaxone and Calcium-containing Products
FDA is updating earlier recommendations about the interaction between the antibiotic ceftriaxone and intravenous products that contain calcium. In certain circumstances, this interaction can cause dangerous precipitates to form. Ceftriaxone is sold... Source: www.accessdata.fda.gov Preventing Medical Errors: Avoiding Errors with Lamictal Starter Kits A recent FDA article describes medication errors that occurred with patients using Lamictal starter kits. Lamictal (lamotrigine) is used to treat epilepsy and bipolar disorder. The starter kits give patients the recommended initial dose and dose... Source: www.accessdata.fda.gov Preventing Medical Errors: Warning on Accidental Ingestion of Benadryl Topical Gel FDA and the Institute for Safe Medication Practices (ISMP) recently reported on several cases where people swallowed Benadryl Itch Stopping Gel, an OTC product that's supposed to be used topically. This has led to serious adverse reactions requiring... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Safety Problems with Denture Cleansers FDA wants healthcare professionals to know about two serious safety problems that have occurred in patients who use denture cleansers. The first is the risk of allergic reactions to these products. These reactions can arise soon after the initial u... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Warning on Testosterone Gel Products FDA will require that two topical testosterone gel products carry a boxed warning stating that children could be inadvertently exposed to testosterone if they contact the gel on the skin of another person, and listing specific recommendations to prev... Source: www.accessdata.fda.gov Recalls and Safety Alerts: Alert on Disetronic ACCU-CHEK Spirit Insulin Pumps Disetronic Medical Systems is notifying healthcare professionals and patients about a possible defect with the some of the company's ACCU-CHEK Spirit insulin pumps. The defect can cause the "up" and "down" buttons on these pumps to stop working, ... Source: www.accessdata.fda.gov Preventing Medical Errors: Avoiding Infant Burns from Heel Warmers A recent FDA article in the journal Nursing 2009 warns about the possibility of burns from infant heel warmers. These devices are disposable heat packs used during neonatal care to increase circulation in the infant's heel. Activating the pack prod... Source: www.accessdata.fda.gov Recalls and Safety Alerts: New Safety Information on Tarceva New information has been added to the labeling of the chemotherapy drug Tarceva (erlotinib). The revised labeling now warns about three kinds of serious adverse events: ? Gastrointestinal perforation, which may be fatal. This risk is increased i... Source: www.accessdata.fda.gov July 16, 2009FDA Seeks Public Input on Tobacco Regulation FDA Seeks Public Input on Tobacco Regulation
The U.S. Food and Drug Administration announced today that it is seeking public input on the implementation of its historic new authority overseeing tobacco products in the United States. In a Federal Register notice, the agency invites the public to provide information and share views on a wide range of topics, from product content to advertising and marketing. Source: www.fda.gov Company Recalls Various Products Due to Potential Salmonella Contamination FDA, USDA, CDC investigating; no link to human illnesses at this time. Plainview Milk Products Cooperative, Plainview, Minn., is voluntarily recalling all instant nonfat dried milk, whey protein, fruit stabilizers, and gums (thickening agents) that it has manufactured over the past two years, because they might be contaminated with Salmonella. Source: www.fda.gov FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban The U.S. Food and Drug Administration today announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs. Source: www.fda.gov FDA Confirms E. Coli O157:H7 in Prepackaged Nestlé Toll House Refrigerated Cookie Dough Today, the U.S. Food and Drug Administration announced that it has found E. coli O157:H7 (a bacterium that can cause serious food borne illness) in a sample of prepackaged Nestlé Toll House refrigerated cookie dough currently under recall by the manufacturer and marketer, Nestlé USA. The contaminated sample was collected at Nestlé’s facility in Danville, Va. on June 25, 2009. Source: www.fda.gov |
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